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BackgroundThe Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI:TAC) is an important tool for assessing teacher skill and aspects of the fidelity of mindfulness-based interventions, but prior research on and implementation of the MBI:TAC has used video recordings, which can be difficult to obtain, share for assessments, and which increase privacy concerns for participants. Audio-only recordings might be a useful alternative, but their reliability is unknown.ObjectiveTo assess evaluator perception of the rating process and inter-rater reliability of MBI:TAC ratings using audio-only recordings.MethodsWe prepared audio-only files from video recordings of 21 previously rated Mindfulness-Based Stress Reduction teachers. Each audio recording was rated by 3 trained MBI:TAC assessors drawn from a pool of 12 who had previously participated in rating the video recordings. Teachers were rated by evaluators who had not viewed the video recording and did not know the teacher. We then conducted semi-structured interviews with evaluators.ResultsOn the 6 MBI:TAC domains, the intraclass correlation coefficients (ICCs) for audio recordings ranged from .53 to .69 using an average across 3 evaluators. Using a single rating resulted in lower ICCs (.27-.38). Bland-Altman plots showed audio ratings had little consistent bias compared to video recordings and agreed more closely for teachers with higher ratings. Qualitative analysis identified 3 themes: video recordings were particularly helpful when rating less skillful teachers, video recordings tended to provide a more complete picture for rating, and audio rating had some positive features.ConclusionsInter-rater reliability of the MBI:TAC using audio-only recordings was adequate for many research and clinical purposes, and reliability is improved when using an average across several evaluators. Ratings using audio-only recordings may be more challenging when rating less experienced teachers.

• We explored urban zen integrative therapy (UZIT) interventionist-related variables that may influence intervention fidelity beyond objective measurements after delivering 78 UZIT sessions to 14 pulmonary hypertension patients. • Qualitative analysis revealed contextual themes related to the UZIT delivery: (1) balancing between tailoring and standardization, (2) challenges with delivery, (3) the need for teamwork, and (4) clients' application of UZIT. • The UZIT interventionists' perspectives highlight areas for researchers to consider enhancing intervention fidelity, rigor, and reproducibility of research on tailored multiple-component complementary therapies such as UZIT. Complementary health approaches have shown therapeutic benefits in symptom reduction and improved patients' quality of life for chronic debilitating conditions such as cancer and pulmonary hypertension. Urban Zen Integrative Therapy (UZIT) is a mindfulness-based multicomponent complementary intervention shown to improve symptom management and quality of life in patients with pulmonary hypertension. Consistent intervention delivery across interventionists is critical to test mindfulness-based multicomponent interventions on a larger scale and further implementations as an augmented practice in routine care. The purpose of the study is to explore interventionists' perspectives of UZIT delivery to gain an in-depth understanding of subjective interventionist-related variables that may influence intervention fidelity beyond objective measurements. Two trained Urban Zen Integrative Therapy interventionists provided their perspectives via joint interviews after delivering 78 one-on-one UZIT sessions to 14 pulmonary hypertension patients. A UZIT session incorporates essential oil, gentle movement, positioning, and meditation. Qualitative analysis revealed four main contextual themes related to UZIT delivery adherence: (1) balancing between tailoring and standardization, (2) challenges with delivery, (3) the need for teamwork, and (4) clients' application of UZIT. When mindfulness-based complementary intervention is aimed at affecting behavioral health practice outcomes, comprehensive contextual insights from interventionists' point-of-view can enhance intervention fidelity and help researchers strengthen the conduct of rigorous research. [ABSTRACT FROM AUTHOR]

Intervention fidelity is crucial in ensuring efficient and quality support for students in need. Some coaching strategies have evidenced positive impacts on intervention fidelity and virtual coaching has been emerging in recent years, especially during the COVID‐19 pandemic. However, current literature is still limited in examining the effects of virtual coaching. After adapting an evidence‐based set of in‐person coaching materials and procedures into a virtual delivery format, this study used a multiple baseline design to evaluate the efficacy of the virtual coaching program in supporting interventionists who implemented a small‐group reading intervention. Visual analysis and nonparametric analyses demonstrated considerable improvement in interventionists' fidelity after receiving the virtual coaching program. Additionally, surveys from interventionists indicated positive perceptions toward the coaches and the virtual coaching process. Practical implications of virtual coaching and future research directions are discussed. Practitioner Points: In‐person intervention coaching can be adapted to virtual coaching to increase the accessibility of coaching services.Synchronous virtual coaching involving observation, feedback, and modeling is effective in significantly increasing intervention fidelity.Graduate students could serve as paraprofessionals to provide effective virtual coaching. [ABSTRACT FROM AUTHOR]

When educational interventions are carried out, it is important that they are undertaken in a way that is aligned with the intervention plan: in other words, that they demonstrate fidelity to the intervention. A significant research issue is how fidelity can be monitored in a time-efficient and cost-effective way in classrooms and whether technology could help to provide innovative solutions in this regard. Through collaboration with teachers, this exploratory study sought to ascertain the usability of a web-based fidelity application (WFA). The WFA was being developed as a checklist tool to help teachers monitor the implementation fidelity of a social and emotional learning intervention for 14- to 15-year-old students in Norway. For this qualitative study, data were collected at two time points: (i) through a focus group interview with six teachers who had piloted the WFA prior to the initiation of the intervention; and (ii) via individual interviews with five teachers in the intervention group who had used the WFA during the implementation process. The data were analysed thematically. According to the analysis, the teachers considered that the WFA's features (e.g. layout and registration process) could help support the ease and efficiency of fidelity reporting. They felt that it provided a highly recognisable link with the intervention material. In addition, the teachers provided ideas for further development and potential improvements. In all, the WFA was perceived as having high usability, suggesting its potential value as a useful tool for the collection of fidelity data. This paper highlights the crucial role of teacher participation and the importance of fidelity data in the conduct of educational interventions. It draws attention to the need for user-friendly tools to support teachers to monitor fidelity in ways that do not involve high time and cost burdens. Similar WFAs could be of potential use in many different kinds of educational interventions in classroom settings internationally. [ABSTRACT FROM AUTHOR]

Background: Previous research has shown that lifestyle modification can delay or prevent the onset of type 2 diabetes in high‐risk individuals. The Norfolk Diabetes Prevention Study (NDPS) was a parallel, three‐arm, randomized controlled trial with up to 46 months follow‐up that tested a group‐delivered, theory‐based lifestyle intervention to reduce the incidence of type 2 diabetes in high‐risk groups. The current study aimed to evaluate if the NDPS intervention was delivered to an acceptable standard and if any part(s) of the delivery required improvement. Methods: A sub‐sample of 30, 25 for inter‐rater reliability and audio‐recordings of the NDPS intervention education sessions were assessed independently by two reviewers (CT, TW) using a 12‐item checklist. Each item was scored on a 0–5 scale, with a score of 3 being defined as 'adequate delivery'. Inter‐rater reliability was assessed. Analysis of covariance (ANCOVA) was used to assess changes in intervention fidelity as the facilitators gained experience. Results: Inter‐rater agreement was acceptable (86%). A mean score of 3.47 (SD =.38) was achieved across all items of the fidelity checklist and across all intervention facilitators (n = 6). There was an apparent trend for intervention fidelity scores to decrease with experience; however, this trend was non‐significant (p >.05) across all domains in this small sample. Conclusion: The NDPS was delivered to an acceptable standard by all Diabetes Prevention Facilitators. Further research is needed to better understand how the intervention's delivery characteristics can be optimized and how they might vary over time. [ABSTRACT FROM AUTHOR]

Abstract Background Non-specific low back pain (LBP) commonly presents to primary care, where inappropriate use of imaging remains common despite guideline recommendations against its routine use. Little is known about strategies to enhance intervention fidelity (i.e., whether interventions were implemented as intended) for interventions developed to reduce non-indicated imaging for LBP. Objectives We aim to inform the development of an intervention to reduce non-indicated imaging among general practitioners (GPs) and chiropractors in Newfoundland and Labrador (NL), Canada. The study objectives are: [1] To explore perceived barriers and enablers to enhancing fidelity of training of GPs and chiropractors to deliver a proposed intervention to reduce non-indicated imaging for LBP and [2] To explore perceived barriers and enablers to enhancing fidelity of delivery of the proposed intervention. Methods An exploratory, qualitative study was conducted with GPs and chiropractors in NL. The interview guide was informed by the National Institutes of Health Behavior Change Consortium fidelity checklist; data analysis was guided by the Theoretical Domains Framework (TDF). Participant quotes were coded into TDF domains, belief statements were generated at each domain, and domains relevant to enhancing fidelity of provider training or intervention delivery were identified. Results The study included five GPs and five chiropractors from urban and rural settings. Barriers and enablers to enhancing fidelity to provider training related to seven TDF domains: [1] Beliefs about capabilities, [2] Optimism, [3] Reinforcement, [4] Memory, attention, and decision processes, [5] Environmental context and resources, [6] Emotion, and [7] Behavioural regulation. Barriers and enablers to enhancing fidelity to intervention delivery related to seven TDF domains: [1] Beliefs about capabilities, [2] Optimism, [3] Goals, [4] Memory, attention, and decision processes, [5] Environmental context and resources, [6] Social influences, and [7] Behavioural regulation. Conclusion The largest perceived barrier to attending training was time; perceived enablers were incentives and flexible training. Patient pressure, time, and established habits were perceived barriers to delivering the intervention as intended. Participants suggested enhancement strategies to improve their ability to deliver the intervention as intended, including reminders and check-ins with researchers. Most participants perceived intervention fidelity as important. These results may aid in the development of a more feasible and pragmatic intervention to reduce non-indicated imaging for GPs and chiropractors in NL.

Background: Reducing household air pollution (HAP) to levels associated with health benefits requires nearly exclusive use of clean cooking fuels and abandonment of traditional biomass fuels. Methods: The Household Air Pollution Intervention Network (HAPIN) trial randomized 3,195 pregnant women in Guatemala, India, Peru, and Rwanda to receive a liquefied petroleum gas (LPG) stove intervention (n = 1,590), with controls expected to continue cooking with biomass fuels (n = 1,605). We assessed fidelity to intervention implementation and participant adherence to the intervention starting in pregnancy through the infant’s first birthday using fuel delivery and repair records, surveys, observations, and temperature-logging stove use monitors (SUMs). Results: Fidelity and adherence to the HAPIN intervention were high. Median time required to refill LPG cylinders was 1 day (interquartile range 0–2). Although 26% (n = 410) of intervention participants reported running out of LPG at some point, the number of times was low (median: 1 day [Q1, Q3: 1, 2]) and mostly limited to the first four months of the COVID-19 pandemic. Most repairs were completed on the same day as problems were reported. Traditional stove use was observed in only 3% of observation visits, and 89% of these observations were followed up with behavioral reinforcement. According to SUMs data, intervention households used their traditional stove a median of 0.4% of all monitored days, and 81% used the traditional stove

As the most common setting where youth access behavioral healthcare, the education sector frequently employs training and follow-up consultation as cornerstone implementation strategies to promote the implementation of evidence-based practices (EBPs). However, these strategies alone are not sufficient to promote desirable implementation (e.g., intervention fidelity) and youth behavioral outcomes (e.g., mitigated externalizing behaviors). Theory-informed pragmatic pre-implementation enhancement strategies (PIES) are needed to prevent the lackluster outcomes of training and consultation. Specifically, social cognitive theory explicates principles that inform the design of PIES content and specify mechanisms of behavior change (e.g., "intentions to implement" (ITI)) to target increasing providers' responsiveness to training and consultation. This triple-blind parallel randomized controlled trial preliminarily examined the efficacy of a pragmatic PIES based on social cognitive theories (SC-PIES) to improve implementation and youth behavioral outcomes from universal preventive EBPs in the education sector. Teachers from a diverse urban district were recruited and randomly assigned to the treatment (SC-PIES; ntreatment = 22) or active control condition (administrative meeting; ncontrol = 21). Based on the condition assigned, teachers received the SC-PIES or met with administrators before their EBP training. We assessed teachers' ITI, intervention fidelity, and youth behavioral outcome (academic engagement as an incompatible behavior to externalizing disorders) at baseline, immediately after training, and 6 weeks afterward. A series of ANCOVAs detected sizeable effects of SC-PIES, where teachers who received SC-PIES demonstrated significantly larger improvement in their ITI, intervention fidelity, and youth behaviors as compared to the control. Conditional analyses indicated that teachers' ITI partially mediated the effect of SC-PIES on intervention fidelity, which in turn led to improved youth behaviors. Findings suggest that theory-informed pragmatic PIES targeting providers' ITI can boost their responsiveness to implementation strategies, as reflected in improved implementation behaviors and youth behavioral outcomes. The results have implications for targeting motivational mechanisms of behavior change and situating preventive implementation strategies at the intersection between the preparation and active implementation stages of an implementation process. Limitations and implications for research and practice are discussed. Clinicaltrials.gov: NCT05240222. Registered on: 2/14/2022. Retrospectively registered. https://clinicaltrials.gov/show/NCT05240222 [ABSTRACT FROM AUTHOR]

Implementation support through coaching—such as with embedded fidelity assessment, performance feedback, modeling, and alliance building—has been empirically supported as a way to increase and sustain interventionists' fidelity levels. However, education research consistently shows that practitioners struggle to monitor and improve interventionists' fidelity using implementation support strategies. One explanation for this type of implementation research-to-practice gap is that evidence-based coaching strategies have significant limitations with respect to their usability, feasibility, and adaptability. This study is the first to experimentally evaluate an evidence-based set of adaptable materials and procedures designed to assess and support the intervention fidelity of school-based interventions. Using a randomized multiple-baseline-across-participants design, we examined the extent to which these materials and procedures would influence intervention adherence and quality of an evidence-based reading intervention. Across all nine interventionist participants, data revealed that the implementation strategies meaningfully improved intervention adherence and quality, and high levels of intervention fidelity maintained 1 month after removing the support procedures. Findings are discussed with respect to how these materials and procedures address a critical need within school-based research and practice as well as how they may help to inform and address the implementation research-to-practice gap in education. [ABSTRACT FROM AUTHOR]

Background: NHS England commissioned four independent service providers to pilot low‐calorie diet programmes to drive weight loss, improve glycaemia and potentially achieve remission of Type 2 Diabetes across 10 localities. Intervention fidelity might contribute to programme success. Previous research has illustrated a drift in fidelity in the design and delivery of other national diabetes programmes. Aims: (1) To describe and compare the programme designs across the four service providers; (2) To assess the fidelity of programme designs to the NHS England service specification. Methods: The NHS England service specification documents and each provider's programme design documents were double‐coded for key intervention content using the Template for Intervention Description and Replication Framework and the Behaviour Change Technique (BCT) Taxonomy. Results: The four providers demonstrated fidelity to most but not all of the service parameters stipulated in the NHS England service specification. Providers included between 74% and 87% of the 23 BCTs identified in the NHS specification. Twelve of these BCTs were included by all four providers; two BCTs were consistently absent. An additional seven to 24 BCTs were included across providers. Conclusions: A loss of fidelity for some service parameters and BCTs was identified across the provider's designs; this may have important consequences for programme delivery and thus programme outcomes. Furthermore, there was a large degree of variation between providers in the presence and dosage of additional BCTs. How these findings relate to the fidelity of programme delivery and variation in programme outcomes and experiences across providers will be examined. [ABSTRACT FROM AUTHOR]

Fidelity to intervention protocol is linked to best outcomes for individuals with autism spectrum disorder (ASD; see Boyd & Corley [Autism 5(4):430-441, 2001]; Pellecchia et al. [J Autism Dev Disord 45(9):2917-2927, 2015]); however, fidelity measurement tools that are both accurate and feasible for community use are often not available. In this paper we explore methods for validated simplification of fidelity assessment procedures toward the goal of increased use in clinical practice. Video recordings (n = 36) of therapists working with children with ASD were coded using three variations of fidelity assessment methodology (trial-by-trial, 5-point Likert Scale, and 3-point Likert Scale), and the results were compared for exact agreement, mastery criterion agreement, and overall reliability. The results indicated overall a very high percentage of exact agreement (mean 99.44%, range 94.4-100%) and excellent reliability (mean Krippendorff's alpha [Kα] 1.0) between the trial-by-trial and 5-point Likert Scale across all components; however, the 3-point method may be viewed as being the more feasible strategy within community programs.

Background Health services interventions are typically more effective in randomised controlled trials than in routine healthcare. One explanation for this ‘voltage drop', i.e. reduction in effectiveness, is a reduction in intervention fidelity, i.e. the extent to which a programme is implemented as intended. This article discusses how to optimise intervention fidelity in nationally implemented behaviour change programmes, using as an exemplar the National Health Service Diabetes Prevention Programme (NHS-DPP); a behaviour change intervention for adults in England at increased risk of developing Type 2 diabetes, delivered by four independent provider organisations. We summarise key findings from a thorough fidelity evaluation of the NHS-DPP assessing design (whether programme plans were in accordance with the evidence base), training (of staff to deliver key intervention components), delivery (of key intervention components), receipt (participant understanding of intervention content), and highlight lessons learned for the implementation of other large-scale programmes.Results NHS-DPP providers delivered the majority of behaviour change content specified in their programme designs. However, a drift in fidelity was apparent at multiple points: from the evidence base, during programme commissioning, and on to providers’ programme designs. A lack of clear theoretical rationale for the intervention contents was apparent in design, training, and delivery. Our evaluation suggests that many fidelity issues may have been less prevalent if there was a clear underpinning theory from the outset.Conclusion We provide recommendations to enhance fidelity of nationally implemented behaviour change programmes. The involvement of a behaviour change specialist in clarifying the theory of change would minimise drift of key intervention content. Further, as loss of fidelity appears notable at the design stage, this should be given particular attention. Based on these recommendations, we describe examples of how we have worked with commissioners of the NHS-DPP to enhance fidelity of the next roll-out of the programme.

In taking stock of educational coaching research, I consider the extant literature and content of four articles comprising a special issue of the Journal of School Psychology (viz., Glover et al., 2022; Pas et al., 2022; Pianta et al., 2022; Reddy et al., 2022). Before reviewing these specific articles, the thesis offered for the broader field is that without the solid foundation afforded by the school consultation literature, the science of educational coaching would not be as advanced as it is today. Following a description of each study and comparisons between/among them, I consider unique and shared aspects of consultation and educational coaching. The article concludes with four proposed directions for future coaching research based on prior consultation research: (a) documenting coaching procedural integrity and intervention fidelity/integrity to an equal degree, (b) changing teacher behavior utilizing social influence/behavior change frameworks, (c) incorporating greater use of technology (i.e., telecoaching), and (d) moving toward the concept of prescriptive coaching. [ABSTRACT FROM AUTHOR]

School-based coaching has emerged as an effective approach for enhancing school personnel's knowledge, implementation skills, and wellbeing, as well as student achievement and behavior. This article introduces the special issue Advancing the Science of Coaching in Education, highlighting four large-scale, rigorous investigations on the effects of coaching and possible contextual variables that influence effective coaching in education. Two studies (Glover et al., 2022; Pianta et al., 2022) assessed how components of coaching (e.g., feedback, practice) may mediate or moderate classroom practices and/or teacher-student interactions that lead to improved student learning. One study (Pas et al., 2022) examined fidelity profiles of motivational interviewing embedded coaching on classroom practices and student behavior in middle school. The final study (Reddy et al., 2022) examined the effects of behavior support coaching on paraprofessional implementation of research-based behavior interventions, wellbeing, and elementary school student social behavior. This article spotlights common elements across studies and offers directions for research and innovation. The special issue closes with a commentary (Erchul, 2022) on the contributions of school consultation research to contemporary coaching research and offers recommendations for bridging research to practice. [ABSTRACT FROM AUTHOR]

Background: Non-specific low back pain (LBP) commonly presents to primary care, where inappropriate use of imaging remains common despite guideline recommendations against its routine use. Little is known about strategies to enhance intervention fidelity (i.e., whether interventions were implemented as intended) for interventions developed to reduce non-indicated imaging for LBP. Objectives: We aim to inform the development of an intervention to reduce non-indicated imaging among general practitioners (GPs) and chiropractors in Newfoundland and Labrador (NL), Canada. The study objectives are: [1] To explore perceived barriers and enablers to enhancing fidelity of training of GPs and chiropractors to deliver a proposed intervention to reduce non-indicated imaging for LBP and [2] To explore perceived barriers and enablers to enhancing fidelity of delivery of the proposed intervention. Methods: An exploratory, qualitative study was conducted with GPs and chiropractors in NL. The interview guide was informed by the National Institutes of Health Behavior Change Consortium fidelity checklist; data analysis was guided by the Theoretical Domains Framework (TDF). Participant quotes were coded into TDF domains, belief statements were generated at each domain, and domains relevant to enhancing fidelity of provider training or intervention delivery were identified. Results: The study included five GPs and five chiropractors from urban and rural settings. Barriers and enablers to enhancing fidelity to provider training related to seven TDF domains: [1] Beliefs about capabilities, [2] Optimism, [3] Reinforcement, [4] Memory, attention, and decision processes, [5] Environmental context and resources, [6] Emotion, and [7] Behavioural regulation. Barriers and enablers to enhancing fidelity to intervention delivery related to seven TDF domains: [1] Beliefs about capabilities, [2] Optimism, [3] Goals, [4] Memory, attention, and decision processes, [5] Environmental context and resources, [6] Social influences, and [7] Behavioural regulation. Conclusion: The largest perceived barrier to attending training was time; perceived enablers were incentives and flexible training. Patient pressure, time, and established habits were perceived barriers to delivering the intervention as intended. Participants suggested enhancement strategies to improve their ability to deliver the intervention as intended, including reminders and check-ins with researchers. Most participants perceived intervention fidelity as important. These results may aid in the development of a more feasible and pragmatic intervention to reduce non-indicated imaging for GPs and chiropractors in NL. [ABSTRACT FROM AUTHOR]

Background People with dementia find it increasingly difficult to carry out daily activities (activities of daily living), and may require increasing support from family carers. Researchers in the Netherlands developed the Community Occupational Therapy in Dementia intervention, which was delivered in 10 1-hour sessions over 5 weeks to people with dementia and their family carers at home. Community Occupational Therapy in Dementia was found to be clinically effective and cost-effective. Objectives Translate and adapt Community Occupational Therapy in Dementia to develop the Community Occupational Therapy in Dementia - the UK version intervention and training programme and to optimise its suitability for use within the UK. To estimate the clinical effectiveness and cost-effectiveness of Community Occupational Therapy in Dementia - the UK version for people with mild to moderate dementia and their family carers compared with treatment as usual. Design The development phase used mixed methods to develop Community Occupational Therapy in Dementia - the UK version: translation, expert review, and adaptation of the manual and training materials; training occupational therapists; focus groups and interviews, including occupational therapists, managers, people with dementia and family carers; consensus conference; and an online survey of occupational therapists to scope UK practice. A multicentre, two-arm, parallel-group, single-blind individually randomised pragmatic trial was preceded by an internal pilot. Pairs were randomly allocated between Community Occupational Therapy in Dementia - the UK version and treatment as usual. A cost–utility analysis, fidelity study and qualitative study were also completed. Setting Community services for people with dementia across England. Participants People with mild to moderate dementia recruited in pairs with a family carer/supporter. Interventions Community Occupational Therapy in Dementia - the UK version is an activity-based, goal-setting approach for people with dementia and family carers, and is delivered at home by an occupational therapist for 10 hours over 10 weeks. Treatment as usual comprised the usual local service provision, which may or may not include standard occupational therapy. Main outcome measures Data were collected through interviews conducted in person with dyads at baseline and at 12 and 26 weeks post randomisation, and then over the telephone with a reduced sample of just carers at 52 and 78 weeks post randomisation. The primary outcome was the Bristol Activities of Daily Living Scale at 26 weeks. The secondary outcomes were as follows: person with dementia – cognition, activities of daily living, quality of life and mood; carer – sense of competence, quality of life and mood; all participants – social contacts, leisure activities and serious adverse events. Results The Community Occupational Therapy in Dementia manual and training materials were translated and reviewed. In total, 44 occupational therapists were trained and delivered Community Occupational Therapy in Dementia to 130 pairs. A total of 197 occupational therapists completed the survey, of whom 138 also provided qualitative data. In total, 31 people attended the consensus conference. Community Occupational Therapy in Dementia - the UK version has more flexibility than Community Occupational Therapy in Dementia in terms of content and delivery; for example, occupational therapists can use the wider range of assessment tools that are already in regular use within UK practice and the time span for delivery is 10 weeks to better meet the needs of pairs and be more feasible for services to deliver. In total, 31 occupational therapists provided Community Occupational Therapy in Dementia - the UK version within the randomised controlled trial. A total of 468 pairs were randomised (249 pairs to Community Occupational Therapy in Dementia - the UK version, 219 pairs to treatment as usual). People with dementia ranged in age from 55 to 97 years (mean 78.6 years), and family carers ranged in age from 29 to 94 years (mean 69.1 years). The majority of those with dementia (74.8%) were married; 19.2% lived alone. Most family carers (72.6%) were spouses but 22.2% were adult children. At 26 weeks, 406 (87%) pairs remained in the trial, and the Bristol Activities of Daily Living Scale total score did not differ at the 5% level when comparing groups (adjusted mean difference estimate 0.35, 95% confidence interval –0.81 to 1.51; p = 0.55). The adjusted (for baseline Bristol Activities of Daily Living Scale total score and randomised group) intracluster correlation coefficient estimate at week 26 was 0.043. There were no significant differences in secondary outcomes. At 52 and 78 weeks, there were no differences between the two groups in Bristol Activities of Daily Living Scale total score and secondary outcomes. The probability that Community Occupational Therapy in Dementia - the UK version is cost-effective at a threshold of willingness to pay per quality-adjusted life-year of £20,000 is 0.02%. In the qualitative interviews, participants reported positive benefits and outcomes. Of the 249 pairs allocated to Community Occupational Therapy in Dementia - the UK version, 227 reached the goal-setting phase, and 838 of the 920 goals set (90.8%) were fully or partially achieved. Limitations The development phase took longer than estimated because of translation time and organisational delays in delivering the intervention. Recruitment to the randomised controlled trial took longer than expected. Fidelity overall was moderate, with variation across sites and therapists. It is possible that Community Occupational Therapy in Dementia - the UK version did not work well in the UK service model in which usual care differs from that in the Netherlands. Conclusions This programme used a rigorous process to develop Community Occupational Therapy in Dementia - the UK version but found no statistical evidence of clinical effectiveness or cost-effectiveness compared with usual care. Qualitative findings provided positive examples of how Community Occupational Therapy in Dementia - the UK version had enabled people to live well with dementia. Future work Developing tools to measure more meaningful outcomes, such as goals achieved or the quantity and quality of activity participation, with less reliance on proxy data, to collect the views and experiences of people with dementia themselves. Trial registration This trial was registered as ISRCTN10748953 (WP3 and WP4). Funding This project was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 11, No. 5. See the NIHR Journals Library website for further project information. Plain language summary Maintaining everyday and meaningful activities can be difficult for a person with dementia. Their family carer/supporter can feel stressed from needing to give increasing support. Occupational therapists assist people to improve their health and well-being by helping them to do the activities that are important to them. Dutch researchers developed an occupational therapy programme for people with mild to moderate dementia and their supporters. Delivered at home, it improved the person’s ability to carry out daily activities, plus their mood and quality of life. Supporters’ sense of competence, mood and quality of life also improved, and it was also value for money. We built on this by translating and adapting the Dutch materials to develop a version better suited to the UK health and social care services context: Community Occupational Therapy in Dementia – UK version. The Community Occupational Therapy in Dementia – UK version comprises 10 hours of occupational therapy provided at home over 10 weeks. We tested whether or not it was more beneficial in terms of helping people with dementia to continue with activities and improving mood and quality of life than the usual service provided (treatment as usual), which may or may not include occupational therapy. In total, 468 pairs comprising a person with dementia and their supporter agreed to take part. Pairs were allocated at random to receive either The Community Occupational Therapy in Dementia – UK version or treatment as usual. We asked questions about daily activities performance, quality of life, mood, and the health and social care services used. We did this at the beginning of the programme and again at 12, 26, 52 and 78 weeks. The statistical analysis showed no evidence that Community Occupational Therapy in Dementia – UK version benefited the pairs on the outcomes selected or was value for money compared with the usual care already provided. We spoke in depth to some of the pairs and occupational therapists who participated in Community Occupational Therapy in Dementia – UK version, and they provided positive examples of meaningful activities that they had resumed or established as a result of the programme. Future research should develop ways of measuring the outcomes that really matter to people with dementia and their supporters, and to collect the views of people with dementia themselves. Scientific summary Background People with dementia find it increasingly difficult to carry out activities, and require increasing support from their family carers, who often experience stress. Occupational therapists support people to improve their health and well-being by enabling them to participate in activities that are meaningful to them. Researchers in the Netherlands developed the Community Occupational Therapy in Dementia (COTiD) intervention, in which occupational therapists delivered in 10 1-hour sessions over 5 weeks to people with mild to moderate dementia and their family carers at home. The Dutch researchers found that COTiD improved the person with dementia’s ability to perform daily living activities [activities of daily living (ADL)], quality of life and mood; improved their family carer’s sense of competence, quality of life and mood; and was cost-effective. Aims and objectives The aim of this applied research programme funded by the National Institute for Health and Care Research (NIHR) was to translate, adapt, evaluate and implement this community occupational therapy intervention designed to promote independence, meaningful activity and quality of life for people with mild to moderate dementia, and thus to benefit their family carers. Objectives •To translate and adapt COTiD into the Community Occupational Therapy in Dementia – UK version (COTiD-UK) intervention and training programme and optimise it for UK use. •To test the feasibility of implementing COTiD within UK health and social care services. •To field test the proposed outcome measures through an internal pilot trial of COTiD-UK compared with treatment as usual (TAU). •To estimate the effectiveness of COTiD-UK in improving the functional independence of people with mild to moderate dementia through a multicentre, pragmatic, single-blind, randomised controlled trial (RCT). •To evaluate cost-effectiveness of COTiD-UK compared with TAU. •To assess the implementation of COTiD-UK through monitoring and budget impact analysis. •To widely disseminate the findings of the Valuing Active Life in Dementia (VALID) research programme. The programme consisted of three phases, including five work packages (WPs): development (WP1 and WP2), piloting and evaluation (WP3 and WP4), and implementation (WP5). Development phase (work packages 1 and 2) Aim To translate and adapt the COTiD guideline and training package to optimise its suitability for use within the UK and, therefore, develop the COTiD-UK intervention ready for evaluation in WP3 and WP4. Method We used a mixed-methods approach, including the following activities. Work package 1: translation and adaptation This WP included the translation, expert review and adaptation of the manual and training materials used to train occupational therapists to deliver COTiD sessions to ‘pairs’ or dyads, comprising a person with mild to moderate dementia and their family carer; focus groups with occupational therapists who delivered COTiD, people with dementia and family carers who had not received COTiD; and semistructured interviews with pairs who had taken part in COTiD, managers of occupational therapists who delivered COTiD, and professionals who had referred pairs to receive COTiD. Finally, a consensus conference was held to finalise the content of the UK version of the intervention, COTiD-UK, with people with dementia and family carers, some of whom had participated in COTiD; occupational therapists who had received the training and delivered COTiD; and managers and other team members. Work package 2: survey of current practice This WP comprised an online survey collecting both quantitative and qualitative data from occupational therapists to scope current UK occupational therapy practice for people with dementia and their carers. Results Work package 1: translation and adaption We established a reference group of UK occupational therapists with experience of working with people with dementia and their family carers in practice. They provided expert opinion and guidance throughout the programme independent of the research team. This Occupational Therapy Reference Group reviewed the translated intervention and training materials, which were then adapted in consultation with the original author. We trained 44 occupational therapists from 10 organisations to deliver COTiD, of whom 28 took part in one of five focus groups. A total of 130 pairs took part in the COTiD sessions. We conducted semistructured interviews with nine pairs: four managers and five referrers. Thirty-nine people who had not received COTiD took part in one of six focus groups. Thirty-one people attended the consensus conference. Work package 2: survey of current practice A total of 230 occupational therapists consented to take part, of whom 197 (86%) provided quantitative data and 138 (60%) provided qualitative data also. Over half of the respondents undertook primarily profession-specific work. Occupational therapy-specific assessments were the most common profession-specific task, and the median time spent per person with dementia was 2.5 hours. Conclusion This phase took twice as long to complete as planned, partly because we underestimated the time needed to complete translation and partly because several organisational and governance issues delayed the occupational therapists delivering the intervention in practice, which in turn delayed the remainder of the data collection activities. We developed the COTiD-UK intervention ready for evaluation in WP3 and WP4. COTiD-UK retains the same aim and principles as COTiD, in that it aims to enable the person with dementia and family carer to carry out meaningful activities. This is achieved through adapting the environment and activity and coaching the family carer in problem-solving and supervision skills. It is similar to COTiD in that it comprises 10 hours of face-to-face intervention provided at home but is more flexible in content and delivery. For example, occupational therapists can use a wider range of assessment and intervention tools that are already in regular use within UK practice, and the time span for delivery is extended from 5 to 10 weeks to better meet the needs of pairs and be more feasible for service delivery. We restructured the training programme into 2 consecutive days followed by a third day once the therapists had delivered COTiD-UK in practice. We also used audio-recording rather than video-recording for the competence assessment process to better meet the needs of UK occupational therapists, many of whom had extensive experience of working with people living with dementia and their family carers or in the community. Piloting and evaluation phase (work packages 3 and 4) Aims Work package 3: internal pilot trial The aim of WP3 was to field test the outcome measures and trial procedures, and finalise the COTiD-UK intervention training, mode of delivery and supervision. Work package 4: full randomised controlled trial To estimate the clinical effectiveness and cost-effectiveness of COTiD-UK compared with TAU. Method We designed WP3 as an internal pilot trial with the intention of progressing to WP4, the full RCT, if it met predefined success criteria. The study design was a multicentre, two-arm, parallel-group, single-blind individually randomised pragmatic trial with an internal pilot. We allocated pairs at random between COTiD-UK and TAU, which may or may not include standard occupational therapy. The primary outcome was the Bristol Activities of Daily Living Scale (BADLS) score at 26 weeks. Secondary outcome measures were as follows: •for person with dementia – cognition (Mini Mental State Examination), ADL performance (Interview of Deterioration in Daily activities of Dementia), quality of life [Dementia Quality of Life (DEMQOL) scale] and mood (Cornell Scale for Depression in Dementia) •for the family carer – sense of competence (Sense of Competence Questionnaire), quality of life (DEMQOL scale) and mood (Hospital Anxiety and Depressions Scale) •for all participants – social contacts, leisure activities and serious adverse events. These outcomes were selected to reflect those measured in the previous trials of COTiD. We undertook a cost–utility analysis of the COTiD-UK intervention relative to TAU using costs and outcome data from the trial. Our analysis adopted the perspective of the NHS and Personal Social Services, as well as a societal perspective. The time horizon was 26 weeks, reflecting the trial’s primary end point. We assessed the effectiveness of the intervention in quality-adjusted life-years (QALYs) estimated from mortality and health-related quality-of-life data collected using the DEMQOL scale for carers, DEMQOL-Proxy for people with dementia and EuroQol-5 Dimensions, five-level version, and health and social care services used for both. We embedded two qualitative studies within the trial: •We explored the experience of undertaking the COTiD-UK intervention from the perspective of people with dementia, family carers and occupational therapists. We conducted semistructured interviews over the telephone with occupational therapists and face to face with pairs. We audio recorded and transcribed all interviews, checked them for accuracy, anonymised them and used inductive thematic analysis. •We explored why pairs declined to take part in the trial. We interviewed a convenience sample of carers identified during the screening process as being eligible but who subsequently declined to take part. We approached them only if we judged that it was unlikely to cause distress. We audio recorded and transcribed the telephone interviews, checked them for accuracy, anonymised them and used inductive thematic analysis. Results The independent Programme Steering Committee reviewed the internal pilot trial and agreed that we should carry the data collected to date forward to the main trial data set. We recruited 15 NHS trusts; however, one trust did not proceed to recruiting pairs owing to unforeseen service reorganisation that resulted in the occupational therapists whom we had trained no longer being available to take part. We trained 44 occupational therapists to deliver COTiD-UK, of whom 32 proceeded to the RCT and were allocated at least one pair each, although one was subsequently unavailable to provide the intervention as planned owing to ill health. We randomised 468 pairs: 249 to COTiD-UK and 219 to TAU. As we expected, the demographic and clinical characteristics of both groups were very similar at baseline. People with dementia ranged in age from 55 to 97 years, with a mean age of 78.6 years, and family carers ranged in age from 29 to 94 years, with a mean age of 69.1 years. The majority of people with dementia (74.8%) were married; 19.2% lived alone. Most family carers (72.6%) were spouses but 22.2% were adult children. At 26 weeks, 406 (87%) pairs remained in the trial. We collected and analysed outcome data from 368 (79%) pairs: 207 (83%) allocated to COTiD-UK and 161 (74%) allocated to TAU. At 26 weeks, there was no evidence to suggest a difference between the COTiD-UK and TAU groups in the primary outcome (BADLS score) or in any secondary outcome. Further analysis of BADLS scores and secondary outcomes at 52 and 78 weeks also showed no difference between the COTiD-UK and TAU groups. The non-adherence rate was 4.64%, compared with the target of 5%. The number of goals set per pair ranged from one to thirteen, with a mean of 4.09 goals. The total number of goals set was 920, of which 729 (79.24%) were achieved, 107 (11.63%) were partially achieved and 84 (9.13%) were not achieved. A total of 239 serious adverse events were recorded over the course of the trial, but none was assessed as being related to the COTiD intervention or trial participation. If decision-makers were willing to pay £20,000 (or £30,000) for a QALY, the probability that COTiD-UK is cost-effective would be 0.02% (or 0.04%). None of these statistical or economic findings changed when we re-ran analyses without adjustment or restricted to complete cases. Qualitative study 1 We interviewed seven occupational therapists and 22 pairs. We identified six themes from the occupational therapist interviews: (1) valuing the occupational focus of COTiD-UK, (2) timing and relationships, (3) achieving goals, (4) developing COTiD-UK knowledge and skills, (5) delivering COTiD-UK within current organisational models, and (6) delivering COTiD-UK in the future. We identified four themes from the interviews with people with dementia and their family carers: (1) achieving goals, (2) working together, (3) effect of dementia and (4) COTiD-UK outcomes. Qualitative study 2 We interviewed 10 family carers and identified two themes: (1) protectiveness and (2) ‘It’s not for us’. Conclusion This trial recruited 97.5% of the target sample, and attrition and non-adherence rates were low. Sites had fewer available occupational therapists than expected, and drop-out rates were higher than expected; therefore, we recruited more sites than originally planned, which took longer than expected. Our design required sites to access researchers, often from the local Clinical Research Network, to recruit participants and collect data, and occupational therapists to deliver the COTiD-UK intervention. Only 2 of the 15 trial sites acquired ‘excess treatment costs’, namely the additional funding that is required within the UK to deliver the clinical intervention being evaluated, as the research grant funding does not cover this. This inevitably reduced capacity to deliver the intervention in some sites because the occupational therapists’ availability was dependent on the goodwill of their managers, who had to balance their support for the study with the need to continue providing the usual service being commissioned. Hence, recruitment rates varied across sites, with some sites exceeding their recruitment target and more not achieving it. The trial statistical results showed no evidence that COTiD-UK was better than the usual care being provided, nor did the economic evaluation provide support for COTiD-UK. By contrast, many people with dementia and family carers described the intervention and its impact in very positive terms, providing examples of how they had resumed old activities and felt empowered to continue participation in future. Implementation phase (work package 5) This phase was amended in response to the cumulative delays outlined above, and the number of data already collected, taking into account the lack of statistically significant results and the growing body of implementation science knowledge. Aim The aims of this WP were to assess the intervention fidelity and to explore why the intervention was, or was not, delivered as planned. Methods We used a longitudinal observational design nested within the trial to assess fidelity to the COTiD-UK intervention. We audio-recorded as many COTiD-UK sessions as was feasible. We developed, piloted and refined fidelity checklists and coding until we achieved good agreement between coders. We purposively sampled 10% of sessions, and estimated percentages of components delivered for each session, occupational therapist and site. We reviewed data collected during the earlier development, piloting and evaluation phases using the theoretical domains framework to identify factors that enabled or hindered intervention delivery. Results A reliable measure of intervention fidelity was developed. Application of this measure found that COTiD-UK was delivered with moderate fidelity overall, although the mean range varied across sites and occupational therapists. The key domains affecting COTiD-UK implementation in practice were knowledge, skills (capability), environmental context and resources (opportunity) and beliefs about capabilities (motivation). Recommendations for future research Traditionally, psychosocial intervention research has focused on assessing outcomes such as cognition, daily living abilities and quality of life as core domains potentially impacted by dementia, using measures of deterioration and impairment. We noted that, in the main, pairs set goals relating to a wider range of activities than those covered within the BADLS, for example leisure, creative, social and community based. Given that over 90% of goals set by the dyads taking part in COTiD-UK were fully or partially achieved, further analysis of the goals set and met could inform the future selection and development of more meaningful occupational outcome measures, tools and processes. It is important to develop ways of measuring the outcomes of complex interventions, such as COTiD-UK, and to measure what is meaningful and prioritised by people with dementia and their family carers. There is also a need to develop such patient-related outcome measures in formats that make them suitable for self-report, to enable data to be collected directly from people with dementia themselves, in turn meaning researchers do not have to rely on proxy data. Implications for practice The trial statistical results did not indicate any benefit of the COTiD-UK intervention as delivered in this trial compared with usual care in the outcomes measured. However, the qualitative findings provided positive examples of dyads resuming or establishing meaningful activities. There is no evidence to suggest that occupational therapy input in general does not continue to be a highly valued and important part of multiprofessional teamworking and service provision. We therefore suggest that occupational therapists do not change their practice, but continue to contribute to community teamwork and memory service provision for people with cognitive problems and their families. Conclusion This applied research programme used a rigorous and thorough process to translate and adapt the original Dutch intervention to the UK version. We found no statistical evidence for clinical effectiveness or cost-effectiveness of COTiD-UK compared with the usual care provided. By contrast, people with dementia, family carers and occupational therapists provided positive examples of meaningful activities being resumed or established. We have shown that it is possible to conduct and effectively deliver a well-designed, high-quality, highly complex clinical trial of occupational therapy across 15 sites and requiring intervention delivery by experienced occupational therapists. Trial registration This trial was registered as ISRCTN10748953 (WP3 and WP4). Funding This project was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 11, No. 5. See the NIHR Journals Library website for further project information.

Background: The Refining and Optimising a behavioural intervention to Support Endocrine Therapy Adherence (ROSETA) programme has developed four intervention components aiming to improve medication adherence in women with early-stage breast cancer. These are (a) text messages, (b) information leaflet, (c) Acceptance and Commitment Therapy-based guided self-help (ACT), (d) side-effect management website. Guided by the Multiphase Optimisation Strategy, our pilot trial will use a fractional factorial design to evaluate the feasibility of undertaking a larger optimisation trial. The pilot will include a process evaluation to maximise learning regarding the fidelity and acceptability of the intervention components before proceeding with a larger trial. The trial process evaluation has three aims: to assess the (1) fidelity and (2) acceptability of the intervention components; and (3) to understand participant’s trial experience, and barriers and facilitators to recruitment and retention. Methods: The process evaluation will use multiple methods. Fidelity of the intervention components will be assessed using self-reported questionnaire data, trial data on intervention component adherence, and observations of the ACT sessions. Acceptability of the intervention components and trial experience will be explored using an acceptability questionnaire and interviews with patients and trial therapists. Trial experience will be assessed using a questionnaire and interviews with participants, while barriers and facilitators to recruitment and retention will be assessed using a questionnaire completed by research nurses and participant interviews. The pilot trial opened for recruitment on 20th May 2022 and was open at the time of submission. Conclusions: This process evaluation will provide information regarding whether the intervention components can be delivered with fidelity within a national healthcare setting and are acceptable to participants. We will also better understand participant experience in a pilot trial with a fractional factorial design, and any barriers and facilitators to recruitment and retention. Registration: ISRCTN registry (ISRCTN10487576, 16/12/2021).

The field of mindfulness-based research and practice is expanding fast. This development calls for a careful evaluation of the merits and scientific underpinnings of newly developed mindfulness-based programs (MBP's). In this viewpoint, we describe a process initiated by two professional mindfulness teacher training organisations (the Dutch Vereniging Mindfulness-based Trainers Nederland, VMBN, and the British Association of Mindfulness-based Approaches, BAMBA) to develop a framework for evaluating the integrity of newly developed MBP's. The framework aims to articulate criteria describing the elements and processes required to ensure that a new MBP meets good practice, adheres to evidenced-based practice, and is attending to the challenge of implementation and scalability. The development and implementation of the criteria are still a 'work in progress'. We hope that this initiative offers a foundation for supporting the MBP field to balance innovation and grassroot community development with aligning to the principles of evidence-based practice. [ABSTRACT FROM AUTHOR]

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Health services interventions are typically more effective in randomised controlled trials than in routine healthcare. One explanation for this 'voltage drop', i.e. reduction in effectiveness, is a reduction in intervention fidelity, i.e. the extent to which a programme is implemented as intended. This article discusses how to optimise intervention fidelity in nationally implemented behaviour change programmes, using as an exemplar the National Health Service Diabetes Prevention Programme (NHS-DPP); a behaviour change intervention for adults in England at increased risk of developing Type 2 diabetes, delivered by four independent provider organisations. We summarise key findings from a thorough fidelity evaluation of the NHS-DPP assessing design (whether programme plans were in accordance with the evidence base), training (of staff to deliver key intervention components), delivery (of key intervention components), receipt (participant understanding of intervention content), and highlight lessons learned for the implementation of other large-scale programmes. NHS-DPP providers delivered the majority of behaviour change content specified in their programme designs. However, a drift in fidelity was apparent at multiple points: from the evidence base, during programme commissioning, and on to providers' programme designs. A lack of clear theoretical rationale for the intervention contents was apparent in design, training, and delivery. Our evaluation suggests that many fidelity issues may have been less prevalent if there was a clear underpinning theory from the outset. We provide recommendations to enhance fidelity of nationally implemented behaviour change programmes. The involvement of a behaviour change specialist in clarifying the theory of change would minimise drift of key intervention content. Further, as loss of fidelity appears notable at the design stage, this should be given particular attention. Based on these recommendations, we describe examples of how we have worked with commissioners of the NHS-DPP to enhance fidelity of the next roll-out of the programme. [ABSTRACT FROM AUTHOR]

Objectives: Peer relationships play a critical role throughout childhood and adolescence. This meta-analysis systematically reviews the effects of mindfulness-based interventions (MBIs) on peer relationships of children and adolescents. Methods: We identified 21 relevant studies from 12 databases. The overall intervention effect size was estimated with the pooled standardized mean difference using random-effects models. Moderator analyses were performed to explore the variability in intervention effects. Fidelity data were synthesized narratively. Risk of bias and publication bias were also assessed. Results: MBIs showed small positive within-group effects (g = 0.48, 95% CI [0.33, 0.62]) and between-group effects (g = 0.40, 95% CI [0.18, 0.62]) on peer relationships. The effects of MBIs on peer relationships varied significantly by participant age and facilitator background. Conclusions: MBIs show promising effects in improving peer relationships among children and adolescents. However, considering the limited evidence currently available, more studies are needed to validate the efficacy of the interventions. Meta-analysis Pre-registration: PROSPERO #CRD42021232836 [ABSTRACT FROM AUTHOR]

Abstract Objectives Intervention fidelity is imperative to ensure confidence in study results and intervention replication in research and clinical settings. Like many brief protocol psychotherapies, Dignity Therapy lacks sufficient evidence of intervention fidelity. To overcome this gap, our study purpose was to examine intervention fidelity among therapists trained with a systematized training protocol. Methods For preliminary fidelity evaluation in a large multi-site stepped wedge randomized controlled trial, we analyzed 46 early transcripts of interviews from 10 therapists (7 female; 7 White, 3 Black). Each transcript was evaluated with the Revised Dignity Therapy Adherence Checklist for consistency with the Dignity Therapy protocol in terms of its Process (15 dichotomous items) and Core Principles (6 Likert-type items). A second rater independently coded 26% of the transcripts to assess interrater reliability. Results Each therapist conducted 2 to 10 interviews. For the 46 scored transcripts, the mean Process score was 12.4/15 (SD = 1.2), and the mean Core Principles score was 9.9/12 (SD = 1.8) with 70% of the transcripts at or above the 80% fidelity criterion. Interrater reliability (Cohen’s kappa and weighted kappa) for all Adherence Checklist items ranged between .75 and 1.0. For the Core Principles items, Cronbach’s alpha was .92. Conclusions Preliminary findings indicate that fidelity to Dignity Therapy delivery was acceptable for most transcripts and provide insights for improving consistency of intervention delivery. The systematized training protocol and ongoing monitoring with the fidelity audit tool will facilitate consistent intervention delivery and add to the literature about fidelity monitoring for brief protocol psychotherapeutic interventions.

Abstract Background Each year, approximately 100,000 individuals receive home health services after a stroke. Evidence has shown the benefits of home-based stroke rehabilitation, but little is known about resource-efficient ways to enhance its effectiveness, nor has anyone explored the value of leveraging low-cost home health aides (HHAs) to reinforce repetitive task training, a key component of home-based rehabilitation. We developed and piloted a Stroke Homehealth Aide Recovery Program (SHARP) that deployed specially trained HHAs as “peer coaches” to mentor frontline aides and help individuals recovering from stroke increase their mobility through greater adherence to repetitive exercise regimens. We assessed the feasibility of SHARP and its readiness for a full-scale randomized controlled trial (RCT). Specifically, we examined (1) the practicability of recruitment and randomization procedures, (2) program acceptability, (3) intervention fidelity, and (4) the performance of outcome measures. Methods This was a feasibility study including a pilot RCT. Target enrollment was 60 individuals receiving post-stroke home health services, who were randomized to SHARP + usual home care or usual care only. The protocol specified a 30-day intervention with four planned in-home coach visits, including one joint coach/physical therapist visit. The primary participant outcome was 60-day change in mobility, using the performance-based Timed Up and Go and 4-Meter Walk Gait Speed tests. Interviews with participants, coaches, physical therapists, and frontline aides provided acceptability data. Enrollment figures, visit tracking reports, and audio recordings provided intervention fidelity data. Mixed methods included thematic analysis of qualitative data and quantitative analysis of structured data to examine the intervention feasibility and performance of outcome measures. Results Achieving the 60-participant enrollment target required modifying participant eligibility criteria to accommodate a decline in the receipt of HHA services among individuals receiving home care after a stroke. This modification entailed intervention redesign. Acceptability was high among coaches and participants but lower among therapists and frontline aides. Intervention fidelity was mixed: 87% of intervention participants received all four planned coach visits; however, no joint coach/therapist visits occurred. Sixty-day follow-up retention was 78%. However, baseline and follow-up performance-based primary outcome mobility assessments could be completed for only 55% of participants. Conclusions The trial was not feasible in its current form. Before progressing to a definitive trial, significant program redesign would be required to address issues affecting enrollment, coach/HHA/therapist coordination, and implementation of performance-based outcome measures. Trial registration ClinicalTrials.gov, NCT04840407 . Retrospectively registered on 9 April 2021

Introduction Strategies are needed to improve the efficacy of paraprofessional home visitors for pregnant women in the United States. This study evaluates the maternal and child outcomes when evidence-based practices (EBP) are replicated with flexibility, rather than fidelity to a manualized intervention. Methods Pregnant mothers (N = 203) in five clinics were recruited in the waiting rooms and randomized to standard clinic care as the control condition (n = 104) or standard care plus home visiting (n = 99). Home visitors (n = 9) were selected, trained in foundational skills common to EBP and four problem domains (weight control, breastfeeding, daily habits, and depression). Independent interviewers assessed targeted outcomes at birth (82%) and 6 months later (83%).ResultsHome visitors, called Mentor Mothers [MM], made an average of 14.9 home visits or telephone contacts (SD = 9; total contacts = 1491) addressing maternal daily habits, breastfeeding, and depression. Intervention and control mothers were similar in weight, Body Mass Index (BMI), depression and social support at baseline and 6 months later. The percentage of low birth weight babies was similar; intervention infants' growth (weight/height Z score) tended to be significantly better compared to the control condition.DiscussionThere are many explanations for the failure to find significant benefits: insufficient statistical power; the benefits of repeated assessments by warm, supportive peers to improve outcomes; or the failure of EBP and the need to maintain replication with fidelity. All study mothers had better outcomes than documented among comparable published samples of low-income, Latina and Korean-American mothers in Los Angeles, CA. ClinicalTrials.gov registration NCT01687634.

Early literacy skills are key indicators of later reading success, and early literacy instruction in early childhood education can support both positive academic and behavioral child outcomes. Dialogic reading (DR) is an evidence-based intervention that targets early literacy skills like oral language, vocabulary, and print concepts. Although research suggests DR has the potential to impact the early literacy skills of young children, intervention fidelity must be maintained for the intervention to be effective. Two single case design studies were conducted in an early childhood setting that together examined (a) the effects of intervention supports on the intervention fidelity of educators performing interventions, and (b) early child literacy outcomes when educators accessed DR intervention supports. Study 1, an alternating treatment design, focused on intervention scripts and an intervention checklist on intervention fidelity. Findings indicated that both supports equivalently increased educators' (N = 4) intervention fidelity, though the educators preferred using a checklist. Study 2, a multiple baseline design, examined the effects of the intervention supports and subsequent increased intervention fidelity on child early literacy across four children. Findings indicated increased book-based vocabulary for children during the intervention phase when intervention fidelity levels were higher. Taken together, the studies suggest intervention fidelity for DR is best delivered with support from checklists or other methods, and that ensuring that DR is delivered as intended may help bolster children's reading skills. [ABSTRACT FROM AUTHOR]

This paper aims at describing the process for assessing the intervention fidelity of a randomized controlled trial (RCT) of an "Adolescent Coping with Depression Course" (ACDC) and to assess the participants' satisfaction with the intervention. We applied the comprehensive fidelity model developed by the National Institutes of Health's Behavior Change Consortium to examine how our intervention met the fidelity requirements under five categories. Data came from a two-arm parallel cluster RCT. Both qualitative and quantitative analyses of the ACDC intervention using the comprehensive fidelity model indicated that the level of fidelity in this study did not reach 100%. However, it was approaching a high level of treatment fidelity. Participants also expressed high levels of satisfaction (M = 3.65, SD =.95). This analysis is important to show how appropriately the intervention was implemented, areas for improvement to increase its fidelity, and to ensure the internal and external validity of the findings. Trial Registration: ISRCTN registry ISRCTN19700389. Registered 6 October 2015. https://doi.org/10.1186/ISRCTN19700389. Full Protocol: https://doi.org/10.1186/s12888-016-0954-y [ABSTRACT FROM AUTHOR]

Abstract Background Intervention fidelity is the core component of a well-designed clinical trial and processes that are used to ensure that the study intervention is delivered as planned. It affects the design and implementation of a study as well as the analysis of the results and interpretation of the findings. The objectives of this study are (a) to describe the methods of assessing the intervention fidelity used in the peer-led chronic pain management program (PAP) and (b) to report the findings on the PAP’s intervention fidelity. Methods To optimize fidelity to the intervention, we used various strategies and measured them in a continuous process using several different approaches: (a) peer volunteer (PV) training workshop, (b) biweekly meetings with the research team, (c) a detailed teaching manual, (d) a fidelity checklist, (e) on-site visits and direct observations, and (f) semi-structured interview. Results The PVs’ attendance was high, and most of them achieved a high level of implementation in following the fidelity checklist. As part of a large clustered RCT, the fidelity assessment was carried out to help determine the effectiveness of the intervention. Conclusions Overall, the PVs successfully delivered the intervention, and the results of the study indicate the effectiveness of the PAP. Trial registration ClinicalTrials.gov NCT03823495 . Registered on 30 January 2019.

Abstract Background Blunt chest wall injuries can lead to complications, especially without early intervention. A blunt Chest Injury Protocol (ChIP) was developed to help improve the consistency of evidence-based care following admission to the emergency department. Implementation strategy fidelity is the extent to which the strategies of implementation are delivered in line with the intended plan. The aim of this study was to assess fidelity to the strategies of the implementation plan developed for ChIP. Methods A retrospective evaluation of strategies used for implementation was performed, specifically the behaviour change techniques (BCTs). BCTs were used as part of an implementation plan derived based on the Behaviour Change Wheel from results from a staff survey at two hospitals. Levels of implementation or adaptation for BCTs were scored by implementers as follows: ‘Were the behaviour change interventions implemented?’ (0 = ‘not implemented’, 1 = partially implemented, and 2 = fully implemented); ‘Were adaptations made to the implementation plan?’, scored 1 (many changes from plan) to 4 (just as planned). Free text explanation to their responses was also collected with supporting evidence and documentation (such as emails, implementation checklists, audit reports, and incident reports). Results There was high overall fidelity of 97.6% for BCTs partially or fully implemented. More than three quarters (32/42, 76.2%) of the BCTs were fully implemented with an additional 9/42 (21.4%) partially implemented. BCTs that were not fully implemented were social support, feedback on behaviour, feedback on outcomes of behaviour, adding objects to the environment, and restructuring the environment. The modes of delivery with poorer implementation or increased adaptations were clinical champions and audit/feedback. Conclusions This study describes the evaluation of implementation strategy fidelity in the acute care context. The systematic use and application of the behaviour change wheel was used to develop an implementation plan and was associated with high implementation strategy fidelity. A fidelity checklist developed during the implementation process may help implementers assess fidelity. Trial registration Trial registered on ANZCTR. Registration number ACTRN12618001548224 , date approved 17/09/2018

Defining the central components of an intervention is critical for balancing fidelity with flexible implementation in both research settings and community practice. Implementation scientists distinguish an intervention's essential components (thought to cause clinical change) and adaptable periphery (recommended, but not necessary). While implementing core components with fidelity may be essential for effectiveness, requiring fidelity to the adaptable periphery may stifle innovation critical for personalizing care and achieving successful community implementation. No systematic method exists for defining essential components a priori. We present the CORE (CO mponents & R ationales for E ffectiveness) Fidelity Method—a novel method for defining key components of evidence-based interventions—and apply it to a case example of reciprocal imitation teaching, a parent-implemented social communication intervention. The CORE Fidelity Method involves three steps: (1) gathering information from published and unpublished materials; (2) synthesizing information, including empirical and hypothesized causal explanations of component effectiveness; and (3) drafting a CORE model and ensuring its ongoing use in implementation efforts. Benefits of this method include: (1) ensuring alignment between intervention and fidelity materials; (2) clarifying the scope of the adaptable periphery to optimize implementation; and (3) hypothesizing—and later, empirically validating—the intervention's active ingredients and their associated mechanisms of change. Interventions that support social communication include several "components," or parts (e.g. strategies for working with children and families, targeting specific skills). Some of these components may be essential for the intervention to work, while others may be recommended or viewed as helpful but not necessary for the intervention to work. "Recommended" components are often described as "adaptable" because they can be changed to improve fit in different settings where interventions are offered or with different individuals. We need to understand which parts of an intervention are essential (and which are adaptable) when translating interventions from research to community settings, but it is challenging to do this before studying an intervention in the community. This article presents the CORE (CO mponents & R ationales for E ffectiveness) Fidelity Method—a new method for defining the essential components of evidence-based interventions—and applies it to a case example of Reciprocal Imitation Teaching, an intervention that parents are taught to deliver with their young children with social communication delays. The CORE Fidelity Method involves three steps: (1) gathering information from multiple sources; (2) integrating information from previous research and theory; and (3) drafting a CORE model for ongoing use. The benefits of using the CORE Fidelity Method may include: (1) improving consistency in intervention and research materials to help all providers emphasize the most important skills or strategies; (2) clarifying which parts of the intervention can be adapted; and (3) supporting future research that evaluates which intervention components work and how they work. [ABSTRACT FROM AUTHOR]

On the Move (OTM), a group exercise program to improve mobility in older adults, is efficacious when delivered by research staff. The next step in the development of OTM as a fully implementable intervention is to conduct an effectiveness study in which the intervention is delivered in community settings by community providers. We describe the methods of a hybrid 1 cluster randomized, single-blind, intervention trial to compare the effectiveness of OTM to a delayed intervention control in 502 community-dwelling older adults across 44 sites. OTM classes are taught by certified instructors in the community twice a week for 12 weeks. Control centers receive no intervention for the first 12 weeks followed by 12-weeks of OTM classes. Participants are assessed at baseline, 12 and 24 weeks. The primary outcome is gait speed. Intervention fidelity, measured by adherence and competence in intervention delivery, is assessed by review of instructor intervention diaries and observation. Organizational, instructor, and participant-level factors which may impact fidelity are assessed using questionnaires, focus groups, and structured interviews. The findings of this trial will 1) establish the effectiveness of OTM on improvements in walking and post-intervention persistence of benefits, 2) assess intervention fidelity and identify the impact of organizational, instructor, and participant level factors on fidelity, and 3) determine the extent to which fidelity moderates the effectiveness of OTM. The information derived from this project will provide valuable insight into the real-world effectiveness of OTM as a health promotion program for improving mobility in older adults. [ABSTRACT FROM AUTHOR]

Abstract Background Focused antenatal care is directed at sustaining maternal health and improving fetal wellbeing to ensure birth of a healthy neonate. Failure to implement focused antenatal care can result in inability to reduce maternal and perinatal morbidity and mortality in low income countries. Due to evidence-practice gaps, however, thousands of maternal, fetal and neonatal lives are still lost every day, mostly from preventable causes. This study aimed to assess focused antenatal care package’s intervention fidelity and its determinant factors in South Wollo Zone, Northeast Ethiopia. Methods A cross-sectional study design was employed and a total of 898 women who gave birth in the last 6 months prior to data collection were included. Also 16 health extension workers, working in ten selected health posts, were included. Interviews and self-administered questionnaires were used to collect data from mothers and health extension workers. Ten [10] health posts were audited to assess availability and functionality of drugs and supplies to provide focused antenatal care. Mothers were asked whether or not the required level of care was provided. Health extension workers were provided with self-administered questionnaires to assess socio-demographic characteristics, reception of training, facilitation strategies for the implementation of focused antenatal care and ability to classify danger signs. Multilevel linear regression analysis was performed to identify individual and organizational level’s factors influencing focused antenatal care package intervention fidelity. Results Overall weighted average focused antenatal care package intervention fidelity (implemented as intended/planned) was 49.8% (95% CI: 47.7–51.8), which means the average number of focused antenatal care package interventions women received is 49.8%. Health extension workers implemented 55.1% and skilled providers (nurses, midwives, health officers or medical doctors) 44.9% of focused antenatal care package interventions. Overall antenatal care coverage, irrespective of frequency (at least one visit), was 752/898 women (83.7%; 95% CI: 81.3–86.1); 263/752 women (35.0%; 95% CI: 31.6–38.4) received at least four antenatal visits and only 46/752 women (6.1%; 95% CI: 4.4–7.8) received all recommended components of focused antenatal care. Previous pregnancy-related problems, paternal education and implementation of facilitation strategies were found to be significant factors enhancing focused antenatal care package intervention fidelity. Conclusion Focused antenatal care package intervention fidelity in the study area was low; this may imply that the current level of maternal, perinatal and neonatal mortality might be partly due to the low level of focused antenatal care intervention fidelity. Improving implementation of facilitation strategies is highly required to contribute to the reduction of those mortalities.

Evaluating effects of different macronutrient diets in randomized trials requires well defined infrastructure and rigorous methods to ensure intervention fidelity and adherence. This controlled feeding study comprised two phases. During a Run-in phase (14–15 weeks), study participants (18–50 years, BMI, ≥27 kg/m2) consumed a very-low-carbohydrate (VLC) diet, with home delivery of prepared meals, at an energy level to promote 15 ± 3% weight loss. During a Residential phase (13 weeks), participants resided at a conference center. They received a eucaloric VLC diet for three weeks and then were randomized to isocaloric test diets for 10 weeks: VLC (5% energy from carbohydrate, 77% from fat), high-carbohydrate (HC)-Starch (57%, 25%; including 20% energy from refined grains), or HC-Sugar (57%, 25%; including 20% sugar). Outcomes included measures of body composition and energy expenditure, chronic disease risk factors, and variables pertaining to physiological mechanisms. Six cores provided infrastructure for implementing standardized protocols: Recruitment, Diet and Meal Production, Participant Support, Assessments, Regulatory Affairs and Data Management, and Statistics. The first participants were enrolled in May 2018. Participants residing at the conference center at the start of the COVID-19 pandemic completed the study, with each core implementing mitigation plans. Before early shutdown, 77 participants were randomized, and 70 completed the trial (65% of planned completion). Process measures indicated integrity to protocols for weighing menu items, within narrow tolerance limits, and participant adherence, assessed by direct observation and continuous glucose monitoring. Available data will inform future research, albeit with less statistical power than originally planned. [ABSTRACT FROM AUTHOR]

Background: Each year, approximately 100,000 individuals receive home health services after a stroke. Evidence has shown the benefits of home-based stroke rehabilitation, but little is known about resource-efficient ways to enhance its effectiveness, nor has anyone explored the value of leveraging low-cost home health aides (HHAs) to reinforce repetitive task training, a key component of home-based rehabilitation. We developed and piloted a Stroke Homehealth Aide Recovery Program (SHARP) that deployed specially trained HHAs as "peer coaches" to mentor frontline aides and help individuals recovering from stroke increase their mobility through greater adherence to repetitive exercise regimens. We assessed the feasibility of SHARP and its readiness for a full-scale randomized controlled trial (RCT). Specifically, we examined (1) the practicability of recruitment and randomization procedures, (2) program acceptability, (3) intervention fidelity, and (4) the performance of outcome measures. Methods: This was a feasibility study including a pilot RCT. Target enrollment was 60 individuals receiving post-stroke home health services, who were randomized to SHARP + usual home care or usual care only. The protocol specified a 30-day intervention with four planned in-home coach visits, including one joint coach/physical therapist visit. The primary participant outcome was 60-day change in mobility, using the performance-based Timed Up and Go and 4-Meter Walk Gait Speed tests. Interviews with participants, coaches, physical therapists, and frontline aides provided acceptability data. Enrollment figures, visit tracking reports, and audio recordings provided intervention fidelity data. Mixed methods included thematic analysis of qualitative data and quantitative analysis of structured data to examine the intervention feasibility and performance of outcome measures. Results: Achieving the 60-participant enrollment target required modifying participant eligibility criteria to accommodate a decline in the receipt of HHA services among individuals receiving home care after a stroke. This modification entailed intervention redesign. Acceptability was high among coaches and participants but lower among therapists and frontline aides. Intervention fidelity was mixed: 87% of intervention participants received all four planned coach visits; however, no joint coach/therapist visits occurred. Sixty-day follow-up retention was 78%. However, baseline and follow-up performance-based primary outcome mobility assessments could be completed for only 55% of participants. Conclusions: The trial was not feasible in its current form. Before progressing to a definitive trial, significant program redesign would be required to address issues affecting enrollment, coach/HHA/therapist coordination, and implementation of performance-based outcome measures. Trial registration: ClinicalTrials.gov, NCT04840407. Retrospectively registered on 9 April 2021 [ABSTRACT FROM AUTHOR]

Objectives: Intervention fidelity is imperative to ensure confidence in study results and intervention replication in research and clinical settings. Like many brief protocol psychotherapies, Dignity Therapy lacks sufficient evidence of intervention fidelity. To overcome this gap, our study purpose was to examine intervention fidelity among therapists trained with a systematized training protocol. Methods: For preliminary fidelity evaluation in a large multi-site stepped wedge randomized controlled trial, we analyzed 46 early transcripts of interviews from 10 therapists (7 female; 7 White, 3 Black). Each transcript was evaluated with the Revised Dignity Therapy Adherence Checklist for consistency with the Dignity Therapy protocol in terms of its Process (15 dichotomous items) and Core Principles (6 Likert-type items). A second rater independently coded 26% of the transcripts to assess interrater reliability. Results: Each therapist conducted 2 to 10 interviews. For the 46 scored transcripts, the mean Process score was 12.4/15 (SD = 1.2), and the mean Core Principles score was 9.9/12 (SD = 1.8) with 70% of the transcripts at or above the 80% fidelity criterion. Interrater reliability (Cohen's kappa and weighted kappa) for all Adherence Checklist items ranged between.75 and 1.0. For the Core Principles items, Cronbach's alpha was.92. Conclusions: Preliminary findings indicate that fidelity to Dignity Therapy delivery was acceptable for most transcripts and provide insights for improving consistency of intervention delivery. The systematized training protocol and ongoing monitoring with the fidelity audit tool will facilitate consistent intervention delivery and add to the literature about fidelity monitoring for brief protocol psychotherapeutic interventions. [ABSTRACT FROM AUTHOR]

The scientific literature on workplace interventions that target individual-level determinants of mental health for primary or secondary prevention is mixed, with many studies failing to show statistically significant, sizeable effects. A methodological characteristic that may explain these mixed findings is fidelity, a multidimensional construct that captures the extent to which an intervention is implemented as intended, in a standardized manner. In this narrative review, we examined the extent to which workplace mental health intervention studies try to enhance or measure the twelve different dimensions of fidelity that have been identified. We conducted comprehensive searches of MEDLINE, Embase, and PsycINFO. Following review, 370 articles were selected for inclusion, of which only 21% explicitly mentioned fidelity. About two-thirds of the articles considered less than half of all relevant fidelity dimensions. Most studies tried to enhance rather than measure fidelity. Only a handful of included studies (n=7, 2%) measured half or more of all relevant fidelity dimensions. Some fidelity dimensions (e.g. theoretical) were considered less often than others (e.g. receipt and enactment). Our review shows that fidelity is insufficiently considered in current workplace mental health literature. We discuss implications for internal and external validity, scalability, and directions for future research. [ABSTRACT FROM AUTHOR]

Teachers' implementation of differentiated supplemental instruction is critical to help students with or at risk for reading-related disabilities acquire early reading and vocabulary skills. This study represents an initial investigation of whether classroom teachers' intervention fidelity (exposure, adherence, and quality) of targeted reading instruction (TRI, formerly called targeted reading intervention), a professional development program with embedded student intervention and weekly webcam literacy coaching support, was related to spring reading and oral vocabulary gains for students at risk for reading-related disabilities. The study also examined whether teachers' years of participation in TRI (1 year vs. 2 years) moderated associations between intervention fidelity and students' reading and oral vocabulary outcomes. Findings suggested that teachers' adherence to TRI strategies was directly associated with students' vocabulary gains as well as word reading skills for teachers in their second year of participation. Furthermore, when teachers provided students with more TRI exposure during their second year of participation, students made greater gains in word reading and reading comprehension. [ABSTRACT FROM AUTHOR]

In this paper, we describe and evaluate the strategies used to maximize intervention fidelity in a randomized controlled trial to examine the efficacy of a sexual assault resistance intervention. The EAAA program was based on the best available theory and evidence on how women can successfully resist sexual coercion from male acquaintances. Extensive protocols for hiring, training, and supervising facilitators were established a priori. Detailed intervention manuals were developed that clearly described program goals, learning objectives, core elements, troubleshooting tips, sections that must be delivered verbatim, adaptations that could be made if necessary, and the ideal and minimum dose. Program sessions were audio-recorded, and a subsample of recordings were scored for adherence to the manuals using detailed Intervention Fidelity Checklists (IFC) developed specifically for this research. The Gearing et al. (2011) Comprehensive Intervention Fidelity Guide (CFIG) was employed retrospectively to provide objectivity to our analysis and help identify what we did well and what we could have done better. The SARE (Sexual Assault Resistance Education) Trial received high scores (38 out of 44 (86%) from each of the first two authors on the CFIG, suggesting a high level of intervention fidelity. Although a potential for bias on the part of the two raters was an obvious limitation, as was our neglection to include measures of implementation receipt, which Gearing et al. (2011) recommended, our analysis underscores the utility in employing methods recommended to enhance intervention fidelity when developing and evaluating evidence-based interventions. [ABSTRACT FROM AUTHOR]

Fidelity (consistency of intervention implementation) is essential to rigorous research. Intervention fidelity maintains study internal validity, intervention reproducibility, and transparency in the research conduct. The purpose of this manuscript is to describe intervention fidelity strategies/procedures developed for a pilot study testing a new palliative care nursing intervention (FamPALcare) for families managing advanced lung disease. The procedures described herein are based on the fidelity best practices recommendations from the NIH Consortium. An evidence‐based checklist guided observational ratings of the fidelity procedures used and the intervention content implemented in each intervention session. Descriptive data on how participants understood (received), enacted, or used the intervention information were summarized. The fidelity checklist observational scores found ≥93% of the planned intervention content was implemented, and the fidelity strategies were adhered to consistently during each intervention session. The small variation (7%) in implementation was expected and related to participants' varying experiences, input, and/or questions. The helpfulness scale items include participants' ability to use home care resources, to anticipate and manage end‐of‐life symptoms, and to use Advance Directive forms. The high ratings (M = 4.4) on the 1–5 (very helpful) Likert Helpfulness Scale verified participants utilized the information from the intervention. Furthermore, there was an improvement in patients' breathlessness scores and completion of Advance Directive forms at 3 months after baseline. It is essential to plan intervention fidelity strategies to use throughout a study and to report fidelity results. [ABSTRACT FROM AUTHOR]

Background: Interventions to change behaviour have substantial potential to impact positively on individual and overall public health. Despite an increasing focus on health behaviour change intervention research, interventions do not always have the desired effect on outcomes, while others have diluted effects once implemented into real-life settings. There is little investment into understanding how or why such interventions work or do not work. Methodological inadequacies of trials of behavioural interventions have been previously suggested as a barrier to the quality and advancement of behavioural research, with intervention fidelity acknowledged as a key area for improvement. However, there is much ambiguity regarding the terminology and conceptualisation of intervention fidelity and a lack of practical guidance regarding how to address it sufficiently, particularly within trials of complex behavioural interventions. Objectives: This article outlines specific issues concerning intervention fidelity within trials of health behaviour change interventions and suggests practical considerations and specific recommendations for researchers, with examples from the literature presented. Conclusions: Recommendations pertain to (1) clarifying how fidelity is defined and conceptualised, (2) considering fidelity beyond intervention delivery, (3) considering strategies to both enhance and assess fidelity, (4) making use of existing frameworks and guidance, (5) considering the quality and comprehensiveness of fidelity assessment strategies, (6) considering the balance between fidelity and adaptation and (7) reporting the use of fidelity enhancement and assessment strategies and their results. Suggestions for future research to improve our understanding of, and ability to, address fidelity in behaviour change interventions are also provided.

Abstract Background Despite increased interest in workplace mental health interventions, the evidence for beneficial effects is mixed. Furthermore, many existing studies lack methodological rigor. We report results from a group randomized control trial to test the efficacy of a vastly popular intervention in Canada, the Road to Mental Readiness (R2MR) program, which has been widely disseminated in military, first responder, and civilian settings. Methods The trial took place among Canadian Armed Forces military recruits completing their basic military qualification (BMQ) training, and randomized 65 platoons (N = 2831) into either (a) an Intervention (R2MR at week 2 of BMQ), or (b) a delayed Intervention Control (R2MR at week 9 of BMQ) condition. The principal investigator, participants, and data collection staff were blinded to platoon condition. Individual-level psychological functioning, resilience, mental health service use attitudes, intentions, and behaviours, and additional covariates were assessed with questionnaires around week 2 (a day or two before Intervention platoons received R2MR), at week 5, and at week 9 (a day or two before the Control platoons received R2MR). Military performance outcomes were obtained from administrative databases. Results The full trial results were mixed; for some outcomes (psychological functioning, resilience, and military performance), we saw no evidence of beneficial effects; where we did see benefits (mental health service use attitudes, intentions, behaviours), the effects were very small, or disappeared over time. Analyses among two subsamples (Group 1: Intervention platoons with a Fidelity Check and their Controls, and Group 2: Intervention platoons without Fidelity Check and their Controls) indicated that for some outcomes (attitudes and help-seeking), under high fidelity conditions, the beneficial effects of R2MR were increased and better sustained; Conversely, under poor fidelity conditions, decreased beneficial effects or even iatrogenic effects were observed. Analyses across three training divisions indicated the larger organizational climate further influences efficacy. Conclusions Our findings paint a very complex picture in which it is made evident that sensible, evidence-informed workplace mental health interventions such as R2MR may work under high fidelity conditions, but may yield no discernable benefit or even inadvertent iatrogenic effects if implemented poorly or without sufficient consideration to the larger organizational context. Trial registration ISRCTN 52557050 Registered 13 October 2016.

Background: Intervention fidelity is the core component of a well-designed clinical trial and processes that are used to ensure that the study intervention is delivered as planned. It affects the design and implementation of a study as well as the analysis of the results and interpretation of the findings. The objectives of this study are (a) to describe the methods of assessing the intervention fidelity used in the peer-led chronic pain management program (PAP) and (b) to report the findings on the PAP's intervention fidelity.Methods: To optimize fidelity to the intervention, we used various strategies and measured them in a continuous process using several different approaches: (a) peer volunteer (PV) training workshop, (b) biweekly meetings with the research team, (c) a detailed teaching manual, (d) a fidelity checklist, (e) on-site visits and direct observations, and (f) semi-structured interview.Results: The PVs' attendance was high, and most of them achieved a high level of implementation in following the fidelity checklist. As part of a large clustered RCT, the fidelity assessment was carried out to help determine the effectiveness of the intervention.Conclusions: Overall, the PVs successfully delivered the intervention, and the results of the study indicate the effectiveness of the PAP.Trial Registration: ClinicalTrials.gov NCT03823495 . Registered on 30 January 2019. [ABSTRACT FROM AUTHOR]

Educational researchers and school-based practitioners are increasingly infusing motivational interviewing (MI) into new and existing intervention protocols to provide support to students, parents, teachers, and school administrators. To date, however, the majority of the research in this area has focused on feasibility of implementation rather than fidelity of implementation. In this manuscript, we will present MI fidelity data from 245 audio-recorded conversations with 113 unique caregivers and 20 coaches, who implemented a school-based, positive parenting intervention. The aggregate fidelity scores across coaches, parents, and sessions provide evidence the training and support procedures were effective in assisting school-based personnel to implement MI with reasonable levels of fidelity in practice settings. Further, results suggest that MI fidelity varied between sessions and coaches and that within-coach variation (e.g., session-level variation in the quality of MI delivered) greatly exceeded between-coach variation. Implications for practice and future research are discussed. [ABSTRACT FROM AUTHOR]

Introduction: Uptake of evidence-based interventions for adolescents and young adults living with HIV (AYA-LWH) in sub-Saharan Africa (SSA) is complex, and cultural differences necessitate local adaptations to enhance effective implementation. Few models exist to guide intervention tailoring, yet operationalizing strategies is critical to inform science and implementation outcomes, namely acceptability, appropriateness, feasibility, fidelity, and sustainability. This paper describes operationalizing the ADAPT-ITT framework applied to a manualized trauma-informed cognitive behavioral therapy (TI-CBT) intervention addressing mental and sexual health for AYA-LWH in SSA in preparation for a randomized controlled trial (RCT).Methods: Phase 1 of the RCT focused on operationalizing ADAPT-ITT steps 3–7 to tailor the intervention for use in eight sites across Botswana, Malawi, South Africa, and Zimbabwe. Well-defined processes were developed to supplement the general guidelines for each step to provide clear, consistent direction on how to prepare and conduct each step, including documenting, assessing, and determining adaptations, while maintaining intervention fidelity. The processes provided efficient standardized step-by-step progression designed for future replication. All sites participated in Phase 1 using the created tools and strategies to translate and present the TI-CBT to community stakeholders for feedback informing local adaptations.Results: The research team developed and operationalized materials guiding adaptation. A translation review process verified local adaptability, maintained core concepts, and revealed differing interpretations of words, idioms, and culturally acceptable activities. Strategically designed tools comprised of feedback and translation verification forms resulted in meticulous management of adaptations. Robust collaborations between investigators, research managers, site personnel, and topical experts maximized multidisciplinary expertise, resulting in ~10–15 personnel per site facilitating, collecting, assessing, and integrating local feedback. Processes and tools operationalized in steps 3–7 effectively addressed implementation outcomes during community engagements (n = 108), focus groups (n = 5–8 AYA-LWH and caregivers per group), and strategic training of youth leaders.Discussion: This paper offers a novel generalizable approach using well-defined processes to guide intervention adaptation building on the ADAPT-ITT framework. The processes strengthen the science of implementation and provide much-needed specificity in adaptation steps to optimize and sustain real-world impact and help researchers and community stakeholders maximize existing infrastructure, culture, and resources to inform implementation strategies.

Abstract Background Chlorhexidine gluconate (CHG) bathing of hospitalized patients may have benefit in reducing hospital-acquired bloodstream infections (HABSIs). However, the magnitude of effect, implementation fidelity, and patient-centered outcomes are unclear. In this meta-analysis, we examined the effect of CHG bathing on prevention of HABSIs and assessed fidelity to implementation of this behavioral intervention. Methods We undertook a meta-analysis by searching Medline, EMBASE, CINAHL, Scopus, and Cochrane’s CENTRAL registry from database inception through January 4, 2019 without language restrictions. We included randomized controlled trials, cluster randomized trials and quasi-experimental studies that evaluated the effect of CHG bathing versus a non-CHG comparator for prevention of HABSIs in any adult healthcare setting. Studies of pediatric patients, of pre-surgical CHG use, or without a non-CHG comparison arm were excluded. Outcomes of this study were HABSIs, patient-centered outcomes, such as patient comfort during the bath, and implementation fidelity assessed through five elements: adherence, exposure or dose, quality of the delivery, participant responsiveness, and program differentiation. Three authors independently extracted data and assessed study quality; a random-effects model was used. Results We included 26 studies with 861,546 patient-days and 5259 HABSIs. CHG bathing markedly reduced the risk of HABSIs (IRR = 0.59, 95% confidence interval [CI]: 0.52–0.68). The effect of CHG bathing was consistent within subgroups: randomized (0.67, 95% CI: 0.53–0.85) vs. non-randomized studies (0.54, 95% CI: 0.44–0.65), bundled (0.66, 95% CI: 0.62–0.70) vs. non-bundled interventions (0.51, 95% CI: 0.39–0.68), CHG impregnated wipes (0.63, 95% CI: 0.55–0.73) vs. CHG solution (0.41, 95% CI: 0.26–0.64), and intensive care unit (ICU) (0.58, 95% CI: 0.49–0.68) vs. non-ICU settings (0.56, 95% CI: 0.38–0.83). Only three studies reported all five measures of fidelity, and ten studies did not report any patient-centered outcomes. Conclusions Patient bathing with CHG significantly reduced the incidence of HABSIs in both ICU and non-ICU settings. Many studies did not report fidelity to the intervention or patient-centered outcomes. For sustainability and replicability essential for effective implementation, fidelity assessment that goes beyond whether a patient received an intervention or not should be standard practice particularly for complex behavioral interventions such as CHG bathing. Trial registration Study registration with PROSPERO CRD42015032523.